Luye Pharma : VOLUNTARY ANNOUNCEMENT - ROTIGOTINE EXTENDED RELEASE MICROSPHERES FOR INJECTION EXEMPTED FROM PHASE II CLINICAL TRIALS IN THE UNITED STATES

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LUYE PHARMA GROUP LTD.

綠 葉 製 藥 集 團 有 限 公 司

(Incorporated in the Bermuda with limited liability)

(Stock Code: 02186)

VOLUNTARY ANNOUNCEMENT

ROTIGOTINE EXTENDED RELEASE MICROSPHERES FOR INJECTION

EXEMPTED FROM

PHASE II CLINICAL TRIALS IN THE UNITED STATES

The board of directors (the ''Board'') of Luye Pharma Group Ltd. (the ''Company'', together with its subsidiaries, the ''Group'') is pleased to announce that the Group's innovative drug, Rotigotine Extended Release Microspheres for injection (''LY03003''), has been approved by the Food and Drug Administration (''FDA'') of the United States of America (the ''United States'' or the ''U.S.'') and is exempted from Phase II dosage exploration clinical trials.

According to the Group's communication with the FDA of the United States, LY03003 will be tested for relative bioavailability with Neupro® transdermal patch, the only rotigotine preparation available on the market. If LY03003 and Neupro® are proved to be bioequivalent, then Phase III treatment effectiveness clinical trials can be further exempted. This would significantly accelerate the research and development process of LY03003, and shorten the time-to-market of the product.

ABOUT LY03003

LY03003 is one of the Group's key central nervous system product candidates developed on a long acting and extended-release formulation platform. The drug is being concurrently developed in the markets of the U.S., China, Europe and Japan, and has completed Phase I clinical trials in both China and the U.S.. The Group owns patents related to the formulation, chemical synthesis methods and impurities of LY03003. The above patents have been acquired in countries such as the U.S., China, Japan, Korea and Europe. The pharmaceutical patent is valid until 2031, and in particular 2032 in the U.S.. The Group plans to register and launch LY03003 in the U.S., China, Japan, Europe and other countries.

LY03003 delivers medication by weekly intramuscular injections. It is the first product worldwide to produce long-term Continuous Dopamine Stimulation. The stable release of the drug in the human body can reduce the ''on-off'' phenomenon common in drug treatments for patients with Parkinson's disease, and significantly improves motor complications common among patients with late-stage Parkinson's disease. It is expected that long-term application of the drug will delay the development of motor complications. At the same time, the Group is further developing Rotigotine Extended Release Microspheres for monthly injections.

With global trends in population ageing, the Board believes that LY03003 has promising market prospects and will enrich the Group's future product portfolio.

ABOUT PARKINSON'S DISEASE

According to the Journal of Neurology, Parkinson's disease is the most common movement disorder and is the second most common neurodegenerative disease. Approximately 1-2% of the population over 65 years of age suffers from Parkinson's disease. This figure increases to 3-5% for the population over 85 years of age.

According to the information of DATA MONITOR, it is expected that the population diagnosed with Parkinson's disease in developed countries such as the U.S., the PIIGS (Portugal, Italy, Ireland, Greece and Spain) countries of Europe and Japan will increase from 1.9 million in 2014 to 2.3 million in 2023. While there are approximately 3 million patients with Parkinson's disease in China, as the ageing problem of the urban population becomes increasingly serious, the new disease incidence is rising at a rate of over 100,000 cases per year. With a continuously increasing number of patients with Parkinson's disease and a growing recognition of the disease, the global market for medicine for Parkinson's disease is promising.

ABOUT CENTRAL NERVOUS SYSTEM PIPELINE PROJECTS

Besides LY03003, the Group has numerous pipeline projects regarding the central nervous system for the concurrent development of China and overseas markets, with projects such as Risperidone Extended Release Microspheres for injection (LY03004) for Schizophrenia and bipolar disorder, ansofaxine hydrochloride extended release tablets (LY03005) under research for depression, and rivastigmine transdermal patch for mild to moderate Alzheimer's disease. The registrations of the above pipeline products are progressing well in strategic markets such as China, the U.S., Europe and Japan, and the products are expected to be launched in these countries and further expanded into the global market.

By Order of the Board LUYE PHARMA GROUP LTD.

Liu Dian Bo

Chairman

Hong Kong, 8 February 2018

As at the date of this announcement, the executive directors of the Company are Mr. LIU Dian Bo, Mr. YANG Rong Bing, Mr. YUAN Hui Xian and Ms. ZHU Yuan Yuan; the non-executive director of the Company is Mr. SONG Rui Lin; and the independent non-executive directors of the Company are Mr. ZHANG Hua Qiao, Professor LO Yuk Lam, Mr. LEUNG Man Kit and Mr. CHOY Sze Chung Jojo.